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Pfizer Global Regulatory Affairs
Pfizer Inc .
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
09August 2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL
AND/OR TRADE SECRET INFORMATION
THAT IS DISCLOSED ONLY IN CONNECTION
WITH THE LICENSING AND/OR
REGISTRATION OF PRODUCTS FOR PFIZER
INC OR ITS AFFILIATED COMPANIES. THIS
DOCUMENT SHOULD NOT BE DISCLOSED OR
USED, IN WHOLE OR IN PART, FOR ANY
OTHER PURPOSE WITHOUT THE PRIOR
WRITTEN CONSENT OF PFIZER INC.
Re: BLA 125742
COVID -19 mRNA Vaccine ( BNT1 62/PF-0 7302048)
Response to s econd round of requested changes and comments on the draft
Package Insert for COMIRNATY
Dear Dr. Gruber ,
Reference is made to the Biologics License Applicatio n (BLA ) submitted 19 May 2021 for
the COVID -19 mRNA Vaccine (BNT162/PF -07302048 ) developed by BioNTech and Pfize r
under BB -IND 1 9736 for the prevention of COVID -19caused by SARS -CoV -2in
individuals ≥16 y ears of age.
The present submission provides response s and updates to the Agency ’s05 August 2021
second round of requested chang es on the draft package insert for COMIRNATY. The
updated draft package insert is provided in Module 1.14.1:
Track change ( PDF and Word )
Annotated ( PDF andWord )
Clean cop y (PDF and Word )
Should y ou have any questions re garding t his submission, or re quireadditional information,
please contact me vi aphone at 215-280-5503 ; via facsi mile at 845 -474-3500; or via e-m ail at
elisa.hark instul [email protected] .
FDA-CBER-2021-5683-0950209
Marion Gru ber, Ph.D. , Director Page 2of 2
BLA 125742 9August 2021
Pfizer Confid ential
Page 2Sincerel y,
Elisa Harkins
Global R egulatory Lead
Global R egulator y Aff airs –Vaccine s
CC: Ramac handr a S. Naik, Ph.D.
FDA-CBER-2021-5683-0950210